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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number INCORRECT ENTRY
Device Problem Leak/Splash (1354)
Patient Problem Hyperglycemia (1905)
Event Date 11/13/2023
Event Type  malfunction  
Event Description
It was reported while using the bd nano¿ 2nd gen pen needle there was leakage.The following was received by the initial reporter: consumer stated, insulin is leaking when taking injection from the patient end of pen needle stated, sometimes the non patient end does not attach to the pen stated, her blood sugar has been high, in the 300's stated, today only, she was 244 before her injection and after taking the injection, her numbers came down to 148 one hour later she does not have or know the exact blood sugar numbers before today, she only mentioned they have been in high 300's stated, she does prime before taking injection and she does not pinch up.
 
Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evalution?yes, d9: returned to manufacturer on: 05-jan-2024 h.6.Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.H3 other text : see h.10.
 
Event Description
It was reported while using the bd nano¿ 2nd gen pen needle there was leakage.The following was received by the initial reporter: consumer stated, insulin is leaking when taking injection from the patient end of pen needle stated, sometimes the non patient end does not attach to the pen stated, her blood sugar has been high, in the 300's stated, today only, she was 244 before her injection and after taking the injection, her numbers came down to 148 one hour later she does not have or know the exact blood sugar numbers before today, she only mentioned they have been in high 300's stated, she does prime before taking injection and she does not pinch up.
 
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Brand Name
BD NANO¿ 2ND GEN PEN NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer (Section G)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer Contact
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key18180524
MDR Text Key328620294
Report Number9616656-2023-01196
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903205745
UDI-Public(01)00382903205745
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberINCORRECT ENTRY
Device Lot NumberINCORRECT ENTRY
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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